NBC 2026 Agenda
Monday, May 11
3:00–4:30 PM Opening Plenary
Speaker: Thomas Hartung, MD, PhD – Johns Hopkins University
Location: Pacific Jewel Ballroom BC
Tuesday, May 12
8:00–9:00 AM Community Meeting Wednesday May 13 in Pacific Jewel A
9:30–10:00 AM Advancing Precision Medicine: Harmonization for Predictive Responses
Speaker: Dhiman Ghosh, PhD – Wave Life Sciences Location: Pacific Jewel BC
10:00–10:30 AM Embedding AI/ML through Ethical and Regulatory Strategy
Speaker: Shannon Ryan – Veritas Automata
Location: Pacific Jewel BC
10:00 AM - 10:30 AM Integrating Advanced Cellular Models, Multiomics, and AI for Safety Prediction
Speaker: Jurre J. Kamphorst, PhD – AstraZeneca
Location: Pacific Jewel A
10:30–11:00 AM AI‑Driven Biomarker and Diagnostic Testing
Speaker: Stephanie A. Pasas‑Farmer, PhD
Location: Pacific Jewel BC
1:00–2:00 PM Keynote: New Approach Methods – From Ugly Ducklings to Beautiful Swans
Speaker: Thomas Hartung, MD, PhD
Moderator: Babak Basiri, PhD – Dyne Therapeutics
Location: Pacific Jewel A
1:00 PM - 2:00 PM Applying Translational Principles Across the Development Lifecycle
Keynote: Implementation of Generative AI for Drug Discovery and Safety
Moderator: Jason Pennucci, MS – Moderna
Keynote Speaker: Weida Tong, PhD (he/him/his) – National Center for Toxicological Research, FDA
Location: Pacific Jewel BC
3:00–3:15 PM Machine Learning for Particle Identification
Speaker: Amber Raines, PhD – Coriolis Pharma U.S.
Location: Pacific Jewel BC
Wednesday, May 13
8:00–9:30 AM Executive Track: Guiding Good Science to Patients
Speakers: Thomas Hartung (Johns Hopkins), Amit Rakhit (BlueRock), Court Turner (LYZZ)
Moderator: Jef Akst – BioSpace
Location: Coral 1–2
10:00–10:30 AM Microfluidics & Personalized Nanomedicine
Speaker: Jennica Zaro, PhD – USC
Location: Pacific Jewel BC
10:00–10:30 AM Translational Bioanalytics for IND Success
Speaker: Vibha Jawa, PhD – EpiVax
Location: Pacific Jewel BC
10:30–11:00 AM | Compliance in Cell & Gene Therapy Manufacturing: Global Trends
Speaker: Yelena Ionova, PharmD – Redica SystemsLocation: Pacific Jewel BC
2:30–3:30 PM Hot Topic Panel: Transparency to Predictive Insights (CRLs)
Moderator: Allison Radwick, PhD – USP
Speakers: Grace McNally (ELIQUENT), Alison Sathe (Redica), Matthew Vankoski (USP)
Location: Coral 1–2
Thursday, May 14
9:00–9:30 AM Subcutaneous Biologic Development Pathways
Speaker: Charles Theuer, MD, PhD – Halozyme
Location: Pacific Jewel A
9:30–10:30 AM Laboratory AI Literacy & Human–AI Integration
Speaker: Richard Jaenisch, MPH
Moderator: Stephanie Pasas‑Farmer, PhD
Location: Coral 1–2
10:00–10:30 AM Biomarker Strategies for Registrational Trials
Speaker: Mohamed Hassanein, PhD – Pfizer
Location: Pacific Jewel A
11:00 AM–
12:00 PM | Keynote: AI in Regulated Bioanalytical Testing
Speaker: Jean‑Claude Marshall, PhD – Moderna
Location: Pacific Jewel BC
1:30 PM - 2:30 PM Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Hot Topic: Organ Chip Clinical Mimicry and NAMs Applied to the Development of New and Follow‑On Therapeutics
Hot Topic Moderator: Weiping Shao, PhD – AstraZeneca
Location: Coral 1-2
1:30 PM - 1:45 PM Clinical Mimicry and Drug Discovery on Organ Chips
Hot Topic Speaker: Chandrav De, PhD (he/him/his) – Wyss Institute at Harvard University
1:45 PM - 2:00 PM Application of NAMs to Immunogenicity Risk Mitigation of New and Follow-on Products
Hot Topic Speaker: Daniela Verthelyi, MD,PhD (she/her/hers) – Thimmus LLC
2:00 PM - 2:30 PM Panel Discussion
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Allison Radwick Ph.D.
Sr Regulatory & Policy Comms Mgr
USP
Coatesville PA
[email protected]
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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Original Message:
Sent: 05-07-2026 14:25
From: Allison Radwick
Subject: May 1 from 1 to 1:45 PM ET AAPS Regulatory Sciences Community Kickoff Meeting
Thank you to everyone that attended the Regulatory Sciences meeting. The slide deck is attached and a draft of the community scientific areas of focus. @HaiAn Zheng and I would love to know what you think. We have also some suggestions on programming and are looking for a Secretary, Scientific Area Focus Team Managers and members for Writing Programming Activity Teams. Get involved in the community and we will work together along with folks form other communities.
If you will be at NBC next week, there is a Regulatory Science, Pharmaceutical Quality, and Global Health Communities Event on Tuesday, May 12 from 8:00–9:00 AM PT in Pacific Jewel BC. I would connect with you if you are at the meeting.
Please add sessions and events at NBC that you are excited about in this thread!.
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Allison Radwick Ph.D.
Sr Regulatory & Policy Comms Mgr
USP
Coatesville PA
[email protected]
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
Original Message:
Sent: 04-27-2026 09:27
From: Allison Radwick
Subject: May 1 from 1 to 1:45 PM ET AAPS Regulatory Sciences Community Kickoff Meeting
Something new is taking shape-and it starts with you. The AAPS Regulatory Sciences Community kicks off with our first meeting-join us to introduce our new leadership, open the floor on topics you want to tackle together, and share the many ways to get involved.
The Translation & Clinical Science Community is also holding their first meeting before ours-check out their page for meeting details and plan to attend both.
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Microsoft Teams meeting
Meeting ID: 275 651 473 042 051
Passcode: kF3Br2Ch
Dial in by phone
Phone conference ID: 145 479 392#
Join on a video conferencing device
Video ID: 113 857 748 1
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Allison Radwick Ph.D.
Sr Regulatory & Policy Comms Mgr
USP
Coatesville PA
[email protected]
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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